Status:
COMPLETED
Comparison of Treatment Simplification by LPV/r vs Current Treatment Continuation in HIV-Infected Patients
Lead Sponsor:
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Collaborating Sponsors:
Abbott
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the efficacy and tolerance of a treatment simplification by a Lopinavir/ritonavir monotherapy versus continuation of current treatment in HIV-infected patients
Detailed Description
Highly active antiretroviral therapy (HAART) has made a significant impact on the natural history of HIV-1 infection, but toxicities and complexities of therapy limit long-term efficacy, and make simp...
Eligibility Criteria
Inclusion
- Age \> or = 18 years
- Confirmed HIV-1 seropositivity
- Antiretroviral treatment stable since 3 months at least
- HIV-1 ARN load \< 50 copies/mL since 6 months at least
- Signed consent form
- No history of treatment failure (= viral load \> 1000 copies/mL) including a protease inhibitor
- No opportunistic infection in the previous 6 months
Exclusion
- Neutrophils \< 750/mm3
- Hemoglobin \< 8 g/dL
- Platelets \< 60,000/mm3
- Creatinin \> 150 micromoles/L
- SGOT \> 5 NUL (Normal Upper Limit)
- SGPT \> 5 NUL
- Current IL-2 treatment
- HBV infection treated or not by lamivudine or tenofovir
- Pregnancy or feeding
- Enrollment in another study not compliant with KALESOLO Study group assignment
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT00140751
Start Date
October 1 2005
End Date
January 1 2008
Last Update
September 19 2013
Active Locations (25)
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1
Hôpital Pierre Zobda-Quitman - Service de Maladies Infectieuses et Tropicales
Fort-de-France, Martinique, France, 97261
2
Centre Hospitalier de la Région Annecienne (CHRA) - Service d'Infectiologie
Annecy, France, 74000
3
Hôpital Jean Verdier - Unité de Maladies Infectieuses
Bondy, France, 93143
4
Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses
Bordeaux, France, 33000